Efficacy of Electrical Vestibular Nerve Stimulation (VeNS) in the Management of Obesity: A Randomized Clinical Trial

Electrical Vestibular Nerve Stimulation (VeNS) Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Reducing Excess Body Weight.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05275790

Enrollment

Registered

2022-03-11

Start date

2022-04-01

Completion date

2022-10-17

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

The aim of this study is to observe the efficacy of electrical vestibular nerve stimulation in the management of obesity. Allocation: Active device (participants act as their own self-control) Endpoint classification: Efficacy Study. The study provides further evidence for the efficacy of electrical vestibular nerve stimulation in the management of obesity.

Interventions

DEVICEVestal device

Battery powered non-invasive neurostimulation device

BEHAVIORALLifestyle intervention

All subjects will be prescribed a diet plan and instructed to follow it for the duration of the 12-week study. The diet plan will be designed by the P.I. who is a qualified, obesity management coach.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Bilateral electrical vestibular nerve stimulation will be administered using a battery-powered vestibular nerve stimulator (ML 1000). Participants will act as their own self-control.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* BMI 30 to 40 kg/m2 * Aged above 18 years

Exclusion criteria

* Current use of any medications or therapy including use of oral contraceptives * Use of dietary supplements known to affect the BMI * Ear problems (assessed during physical examination) * Any severe complications * Unwilling participants

Design outcomes

Primary

Measure	Time frame	Description
Lipid profile	12 weeks	Blood sample to calculate ratio of Total Cholesterol: HDL and LDL

Secondary

Measure	Time frame	Description
Liver function tests	12 weeks	Albumin test
Complete blood count	12 weeks	Complete blood count
Glycated hemoglobin	12 weeks	HbA1c as a percentage
Mean blood glucose	12 weeks	Fasting glucose in mg/dL

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026